FDA approves Novartis’ Exelon Patch to treat mild to moderate AD

Published on September 4, 2012 at 4:51 AM · No Comments

The US Food and Drug Administration has approved a higher dose of Exelon® Patch (rivastigmine transdermal system) for the treatment of people with mild to moderate Alzheimer's disease. The new 13.3 mg/24 h dosage strength of Exelon Patch provides physicians with a new treatment option for patients who are experiencing a decline in overall function and cognition.

"Alzheimer's disease is marked by progressive symptomatic decline, resulting in an increasingly large physical and emotional challenge for the patient and caregiver," said Jeffrey Cummings, MD, Director of the Cleveland Clinic Lou Ruvo Center for Brain Health. "Having multiple options for the treatment of mild to moderate Alzheimer's disease will help physicians better care for patients with the hope of improving function and cognition."

Approval of Exelon Patch 13.3 mg/24 h was based on the 48-week double-blind phase of the OPTIMA study, a novel controlled trial in mild to moderate AD patients who met the pre-defined criteria for functional and cognitive decline on the 9.5mg/24 h dose. Patients treated with the 13.3 mg/24 h patch experienced statistically significant (p<0.05) improvement in their overall function compared to the 9.5 mg/24 h patch as measured by the instrumental activities of daily living scale (ADCS-IADL) at week 48 (a co-primary endpoint). Improvement in cognition (measured by ADAS-Cog) compared to the lower dose was nominally statistically significant at 24 weeks but not at 48 weeks (also a co-primary endpoint). This was one of the longest double-blind cholinesterase inhibitor trials to date.

During the 48-week dose-comparison phase of OPTIMA, no unexpected adverse events (AEs) leading to discontinuation were reported, and the safety profile of the higher dose was consistent with that of the currently approved doses of Exelon Patch. Overall, the percentage of patients with AEs leading to discontinuation was lower in the 13.3 mg/24 h group compared to the 9.5 mg/24 h group (9.6% vs. 12.7%, respectively).

"Family caregivers play a vital role in the Alzheimer's treatment journey by working closely with healthcare providers to choose the right treatment for their loved ones," said John Schall, Chief Executive Officer of the National Family Caregivers Association. "From the caregiver's standpoint, a patch can be visual evidence to help see if their loved one has actually received their medication, so to have an additional option is important."

Exelon Patch is the first transdermal (through the skin) therapy approved for the treatment of people with mild to moderate Alzheimer's disease. It is also approved to treat people with mild to moderate Parkinson's disease dementia.

"Exelon Patch has been used to treat hundreds of thousands of patients over the years, so we are especially pleased that the higher dose is now available to help even more people," said Andre Wyss, President of Novartis Pharmaceuticals Corporation. "We believe in transdermal application and the efficacy of Exelon Patch, and we are committed to continuing our research in Alzheimer's disease."

Source:

Novartis Pharmaceuticals Corporation 

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